Fatigue in Breast Cancer Patients Undergoing Radiotherapy-eSMART-MH

NCT02759549 | Withdrawn DMC

• 1 other identifier: IRB00028295
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine if an avatar-based depression self-management intervention (eSMART-MH) once a week for the duration of the participant's radiation treatment will significantly reduce depressive symptoms. Investigators also seek to explore how women with breast cancer describe their mood using prompted and unprompted speech through electronic social media and interviews. Participants will be randomized into the eSMART-MH group or the theater testing (attention control) group. In addition to the assigned interventions, participants will be asked to complete questionnaires and interviews with the study staff.

Conditions

Breast Cancer

Keywords

Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) score

  The IDS-SR is a self-reported measure in which participants rate the frequency of depression symptoms within the past seven days. Scores range from 0 to 84, with higher score reflecting greater severity of depressive symptoms.

  Baseline, Post Treatment (5-7 weeks)

Secondary Outcomes (9)

• Change in Pittsburgh Sleep Quality Index (PSQI) Score

  Baseline, Post Treatment (5-7 weeks)

• Change in Perceived Stress Scale (PSS) Score

  Baseline, Post Treatment (5-7 weeks)

• Change in Short Form-36 (SF-36) Health Survey Score

  Baseline, Post Treatment (5-7 weeks)

• Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score

  Baseline, Post Treatment (5-7 weeks)

• Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score

  Baseline, Post Treatment (5-7 weeks)

Other Outcomes (17)

• Change in Behavioral Activation for Depression Scale-Short Form (BADS-SF) Score

  Baseline, Post Treatment (5-7 weeks)

• Change in Self-Efficacy for Managing Chronic Disease 6-Item Scale Score

  Baseline, Post Treatment (5-7 weeks)

• Change in Pediatric CARE measure 10 questions (PCM 10Q) Score

  Baseline, Post Treatment (5-7 weeks)

Study Arms (2)

eSMART-MH

EXPERIMENTAL

Participants undergoing radiation treatment for breast cancer will receive the Electronic Self-Management Resource Training for Mental Health (eSMART-MH) intervention.

Behavioral: eSMART-MH; Other: Mobile Mood Tracking (Mood 24/7)

Theater Testing

OTHER

Participants undergoing radiation treatment for breast cancer will participate in a theater testing workshop.

Behavioral: Theater Testing Workshop

Interventions

eSMART-MH BEHAVIORAL

eSMART-MH (Electronic Self-Management Resource Training for Mental Health) is a software, which is set in a 3-D virtual primary care office environment in which a subject interacts with avatar virtual healthcare staff (medical receptionist, medical assistant, providers, and a virtual healthcare coach). The avatars are programmed to behave like humans. The subject moves through the 3-D virtual primary care office and encounters virtual healthcare staff and providers. The subject practices discussing depressive symptoms with avatar healthcare providers and practices self-management skills related to symptoms of depression.The subject also interacts with the health care coach. The health care coach provides the subject with real-time strategies to enhance communication with healthcare providers during their virtual office visit. eSMART-MH will be used once a week throughout the duration of radiation treatment.

eSMART-MH

Mobile Mood Tracking (Mood 24/7) OTHER

Public social media data posted by participants will be accessed and downloaded to a computer program. Permission for the study team to access this data is optional.

eSMART-MH

Theater Testing Workshop BEHAVIORAL

The theater testing workshop consists of one to two one-on-one sessions with study staff during which participants will review a computer program for its content and usability, as well as discuss areas for improvement. Participants will also be asked to complete questionnaires and a attend a brief interview regarding any suggested improvements for the computer program.

Theater Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients seen in the Emory Breast Center at The Emory Clinic and Emory Midtown Hospital who are treated with curative intent.
• Score of 8 or higher on the Inventory of Depressive Symptomology - Self Reported (IDS-SR) test

Sponsors & Collaborators

• Emory University: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (4)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mylin Torres, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 3, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2017
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

US (4)